Tag Archives: regulatory compliance

Preparing for Electronic Batch Records: A “To Do” List for Quality Managers

Preparing for Electronic Batch Records: A “To Do” List for Quality Managers

Quality and manufacturing managers know that a method for documenting and reviewing accurate batch records is the single most important element in a pharmaceutical manufacturing and quality process. That’s because, without accurate batch records, even a well-designed quality system will be vulnerable to audit findings and warning letters. After all, nobody wants to receive a

Regulatory Compliance Starts with Effective Document Management

Effective Document management in Pharma

Document management is an essential function for pharmaceutical companies. It allows them to efficiently store, organize, and retrieve important documents related to drug development, clinical trials, manufacturing, distribution, and other business critical information. Failure to effectively manage these documents can result in serious consequences such as fines, delays in product launch, and even legal action.